Sorrento Announces FDA Authorization to Proceed with Phase 1 Study of Intravenous STI-9167 (COVISHIELD), a Potent Neutralization Antibody Against Omicron BA.2 and Other SARS-CoV-2 Variants of Concern

Rhea-AI Summary

Sorrento Therapeutics (Nasdaq: SRNE) has received FDA clearance for its investigational new drug application (IND) for intravenous STI-9167 (COVISHIELD™) aimed at conducting a Phase 1 safety and pharmacokinetic study in healthy volunteers. Following this, multinational Phase 2/3 trials will assess the drug's efficacy in mild to moderate COVID-19 patients. STI-9167 has shown positive in vitro and in vivo activity against various SARS-CoV-2 variants, including Omicron strains. Sorrento aims to discuss potential Emergency Use Authorization with the FDA based on trial results.

Positive

• FDA cleared IND for STI-9167 (COVISHIELD™) for Phase 1 study.
• STI-9167 demonstrated activity against all tested SARS-CoV-2 variants.
• Plans for multinational Phase 2/3 trials following initial study.

Negative

• None.

• FDA granted IND clearance today for STI-9167 (Intravenous COVISHIELD™) for a Phase 1 safety and pharmacokinetic study in healthy volunteers.
• Initial trials are expected to be followed by a multinational Phase 2/3 trial in both mild and moderate COVID-19 patients.
• STI-9167 has demonstrated in vitro and in vivo activity against all SARS-CoV-2 variants tested, including the Omicron strain BA.1, Omicron BA.1.1 and Omicron BA.2.
  

SAN DIEGO, April 25, 2022 (GLOBE NEWSWIRE) -- Sorrento Therapeutics, Inc. (Nasdaq: SRNE, "Sorrento") today announced that it has received clearance from the FDA for its investigational new drug application (IND) for intravenous (IV) STI-9167 (COVISHIELD) to study the safety and pharmacokinetics in healthy volunteers. STI-9167 is the IV formulation of the intranasal STI-9199 neutralizing antibody.

The Phase 1 study will be conducted at a single clinical site in the US and will be followed by multinational (USA, China and Mexico) Phase 2/3 trials. Sorrento plans to discuss with the FDA the most appropriate end-points for the pivotal study that could result in an Emergency Use Authorization (EUA), if the trials meet the efficacy end-points of the pivotal study.

About Sorrento Therapeutics, Inc. 

Sorrento is a clinical and commercial stage biopharmaceutical company developing new therapies to treat cancer, pain (non-opioid treatments), autoimmune disease and COVID-19. Sorrento's multimodal, multipronged approach to fighting cancer is made possible by its extensive immuno-oncology platforms, including key assets such as fully human antibodies (“G-MAB™ library”), immuno-cellular therapies (“DAR-T™”), antibody-drug conjugates (“ADCs”), and oncolytic virus (“Seprehvec™”). Sorrento is also developing potential antiviral therapies and vaccines against coronaviruses, including Abivertinib, COVI-AMG™, COVISHIELD™, COVI-MSC™ and COVIDROPS™; and diagnostic test solutions, including COVITRACK™ and COVIMARK™.

Sorrento's commitment to life-enhancing therapies for patients is also demonstrated by our effort to advance a first-in-class (TRPV1 agonist) non-opioid pain management small molecule, resiniferatoxin (“RTX”), and SP-102 (10 mg, dexamethasone sodium phosphate viscous gel) (SEMDEXA™), a novel, viscous gel formulation of a widely used corticosteroid for epidural injections to treat lumbosacral radicular pain, or sciatica, and to commercialize ZTlido^® (lidocaine topical system) 1.8% for the treatment of post-herpetic neuralgia (PHN). RTX has been cleared for a Phase II trial for intractable pain associated with cancer and a Phase II trial in osteoarthritis patients. Positive final results from the Phase III Pivotal Trial C.L.E.A.R. Program for SEMDEXA™, its novel, non-opioid product for the treatment of lumbosacral radicular pain (sciatica), were announced in March 2022. ZTlido^® was approved by the FDA on February 28, 2018.

For more information visit www.sorrentotherapeutics.com

Forward-Looking Statements

This press release and any statements made for and during any presentation or meeting contain forward-looking statements related to Sorrento Therapeutics, Inc., under the safe harbor provisions of Section 21E of the Private Securities Litigation Reform Act of 1995 and subject to risks and uncertainties that could cause actual results to differ materially from those projected. Forward-looking statements include statements regarding STI-9167 (COVISHIELD); the therapeutic and clinical potential of STI-9167; the potential safety and efficacy of STI-9167; the preclinical and clinical testing of STI-9167; the expectation of conducting a Phase 1 clinical trial, followed by Phase 2/3 trial(s), to evaluate STI-9167; Sorrento’s plans to discuss with FDA the endpoint criteria for a pivotal study that could result in an Emergency Use Authorization for STI-9167; and Sorrento’s position in the antiviral industry. Risks and uncertainties that could cause our actual results to differ materially and adversely from those expressed in our forward-looking statements, include, but are not limited to: risks related to Sorrento's technologies and prospects, including, but not limited to risks related to seeking regulatory approval for STI-9167; clinical development risks, including risks in the progress, timing, cost, and results of clinical trials and product development programs; risk of difficulties or delays in obtaining regulatory approvals; risks that clinical study results may not meet any or all endpoints of a clinical study and that any data generated from such studies may not support a regulatory submission or approval; risks that prior test, study and trial results may not be replicated in future studies and trials; risks of manufacturing and supplying drug product; risks related to leveraging the expertise of its employees, subsidiaries, affiliates and partners to assist Sorrento in the execution of its product candidates’ strategies; risks related to the global impact of COVID-19; and other risks that are described in Sorrento's most recent periodic reports filed with the Securities and Exchange Commission, including Sorrento's Annual Report on Form 10-K for the year ended December 31, 2021 filed with the Securities and Exchange Commission, including the risk factors set forth in those filings. Investors are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of this release and we undertake no obligation to update any forward-looking statement in this press release except as required by law.

Media and Investor Relations

Contact: Brian Cooley
Email: mediarelations@sorrentotherapeutics.com

Sorrento^® and the Sorrento logo are registered trademarks of Sorrento Therapeutics, Inc.

G-MAB™, DAR-T™, Seprehvec™, SOFUSA™, COVI-AMG™, COVISHIELD™, COVIDROPS™, COVI-MSC™, COVITRACK™ and COVIMARK™ are trademarks of Sorrento Therapeutics, Inc.

SEMDEXA™ is a trademark of Semnur Pharmaceuticals, Inc.

ZTlido^® is a registered trademark owned by Scilex Pharmaceuticals Inc.

All other trademarks are the property of their respective owners.

©2022 Sorrento Therapeutics, Inc. All Rights Reserved.

FAQ

What is the purpose of the STI-9167 clinical trial?

The STI-9167 clinical trial aims to study the safety and pharmacokinetics of the drug in healthy volunteers, followed by assessing its efficacy in COVID-19 patients.

What are the next steps after the Phase 1 trial of STI-9167?

Following the Phase 1 trial, Sorrento plans to initiate multinational Phase 2/3 trials to evaluate STI-9167 in mild and moderate COVID-19 patients.

What variants of SARS-CoV-2 does STI-9167 target?

STI-9167 has shown effectiveness against all tested SARS-CoV-2 variants, including various Omicron strains.

What is the potential market impact of Sorrento's STI-9167?

If successful, STI-9167 could lead to Emergency Use Authorization by the FDA, potentially impacting Sorrento's market presence in antiviral therapies.